Safety, Efficacy and Pharmacokinetics of ALD518 in Patients With Non-Small Cell Lung Cancer-related Fatigue and Cachexia
Status and phase
Conditions
Treatments
Details and patient eligibility
About
The purpose of this study is to asses the safety and efficacy of ALD518 in patients with Non-Small Cell Lung Cancer-Related Fatigue and cachexia (weight-loss).
Full description
This is a phase II, double-blind, randomized, placebo-controlled study of ALD518 in patients with NSCLC related fatigue and cachexia.
It is estimated that a total of 120 patients will be randomized to ALD518 80 mg, 160 mg, 320 mg, or placebo in a 1:1:1:1 ratio.
A total of eight visits (excluding the Screening visit) will take place over a period of 24 weeks: Day 1, Weeks 2, 4, 8, 12, 16, 20, and 24.
Enrolled patients will be screened within a 4 week period (Day 35 to 7). Randomization to treatment will be within a 12 day period (Day 14 to 3), before initial dosing on Day 1.
Patients will receive treatment eight weeks apart (on Day 1, and Weeks 8 and 16). All patients will remain at the clinic for at least 4 hours from the time the infusion is started. Follow-up visits will occur four and eight weeks after the last dose of study drug, at Weeks 20 and 24, respectively.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Confirmed diagnosis of NSCLC incurable by other treatments including surgery
- A ≥5 % loss of body weight in the preceding 3 months
- A C-reactive protein (CRP) concentration ≥ 10 mg/L
- Life Expectancy of at least 12 weeks
Exclusion criteria
- Treatment with chemotherapy, large-field radiotherapy, or surgery for treatment of cancer in the past 30 days
- AST/ALT ≥ 3 x ULN at screening
- Hemoglobin < 8 g/dL at Screening
- History of or active diagnosis of Tuberculosis
Trial design
Primary purpose
Allocation
Interventional model
Masking
124 participants in 4 patient groups, including a placebo group
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal